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Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

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Trial Profile

Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Apr 2024

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At a glance

  • Drugs Aprocitentan (Primary)
  • Indications Resistant hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms PRECISION
  • Sponsors Actelion Pharmaceuticals; Idorsia Pharmaceuticals
  • Most Recent Events

    • 26 Apr 2024 According to an Idorsia Pharmaceuticals Media Release, company announced that the Committee for Medicinal Products for Human Use (CHMP), adopted a positive opinion for the use of JERAYGO (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The CHMP has adopted a positive opinion for the use of 12.5 mg JERAYGO orally once daily.The dose can be increased to 25mg OD for patients tolerating the 12.5mg.
    • 20 Mar 2024 According to an Idorsia Pharmaceuticals Media Release, announced today that the US Food and Drug Administration (FDA) has approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. An investor conference call and webcast will be held on Wed , 20 Mar 2024 15:00hrs CET, to discuss the TRYVIO FDA approval
    • 10 Jan 2024 According to an Idorsia Pharmaceuticals Media Release, company expected to achieve FDA decision for the NDA and EMA decision for the MAA for aprocitentan in resistant hypertension in 2024. Other regulatory filings is under preparation.
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